By Chris Wack
Better Therapeutics said that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy platform intended to treat adults with metabolic dysfunction-associated steatohepatitis.
The FDA’s Breakthrough status is reserved for technologies that demonstrate the potential to be more effective than current standard of care in patients with serious or life-threatening conditions.
The company said it earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events.
The company’s CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes.
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